Crohn's DiseaseNCT02322008
Anti-TNF Therapy in Danish Patients With Inflammatory Bowel Diseases in Clinical Practice
An observational study of Crohn's Disease and Ulcerative Colitis, run by Regionshospitalet Viborg, Skive.
Trial summary
Can genetic markers be used to predict anti-TNF response? A cohort was established to identify SNPs associated with anti-TNF therapy in patients with inflammatory bowel disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn's Disease, Ulcerative Colitis, Inflammatory Bowel Disease
- What is being tested?
- infliximab and adalimumab
- How many people
- 1,035 participants
- Where
- No sites listed yet
- Study dates
- Sep 2009to Mar 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 1035 patients with CD or UC
Who may be able to join
- CD or UC, treated with anti-TNF
Who cannot join
- Missing data
About this study
Can genetic markers be used to predict anti-TNF response? A cohort was established to identify SNPs associated with anti-TNF therapy in patients with inflammatory bowel disease.
- Being tested
- infliximab and adalimumab
- Medical subject headings
- Crohn Disease, Colitis, Ulcerative, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
infliximab and adalimumabBiological
Also called remicade and humira, anti-TNF
In this retrospective, observational study, no interventions were undertaken by the researchers.
What is being measured
The primary outcome is the main question the study is designed to answer.
3-step scale
Best response within 22 weeks
Measured: 22 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2014 (estimated)
- Study startSep 2009
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 1,035 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regionshospitalet Viborg, Skive
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steffen Bank, Regionshospitalet Viborg, Skive
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02322008
- Sponsor's protocol ID
- Anti-TNF, IBD
- Status last verified
- Dec 2014
- First submitted
- 17 Dec 2014
- Last updated
- 23 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Bank S, Andersen PS, Burisch J, Pedersen N, Roug S, Galsgaard J, Turino SY, Brodersen JB, Rashid S, Avlund S, Olesen TB, Green A, Hoffmann HJ, Thomsen MK, Thomsen VO, Nexo BA, Vogel U, Andersen V. Effectiveness of anti-tumour necrosis factor-alpha therapy in Danish patients with inflammatory bowel diseases. Dan Med J. 2015 Mar;62(3):A4994.
PubMed 25748864
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-TNF Therapy in Danish Patients With Inflammatory Bowel Diseases in Clinical Practice
- ClinicalTrials.gov ID
- NCT02322008
- Acronym / sponsor ID
- Anti-TNF, IBD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,035 participants (actual)
- Lead sponsor
- Regionshospitalet Viborg, SkiveUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 22 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Can genetic markers be used to predict anti-TNF response? A cohort was established to identify SNPs associated with anti-TNF therapy in patients with inflammatory bowel disease.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1035 patients with CD or UC
Key inclusion criteria (1 listed)
- CD or UC, treated with anti-TNF
Key exclusion criteria (1 listed)
- Missing data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| infliximab and adalimumabAlso: remicade and humira, anti-TNFIn this retrospective, observational study, no interventions were undertaken by the researchers. | Biological | – |
Primary outcome
3-step scale
Time frame: 22 weeks
Best response within 22 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2014.
- Derived from this study: PubMed 25748864Bank S, Andersen PS, Burisch J, Pedersen N, Roug S, Galsgaard J, Turino SY, Brodersen JB, Rashid S, Avlund S, Olesen TB, Green A, Hoffmann HJ, Thomsen MK, Thomsen VO, Nexo BA, Vogel U, Andersen V. Effectiveness of anti-tumour necrosis factor-alpha therapy in Danish patients with inflammatory bowel diseases. Dan Med J. 2015 Mar;62(3):A4994.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn's Disease and Ulcerative Colitis, run by Regionshospitalet Viborg, Skive.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-step scale (time frame: 22 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02322008, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2014.